Idylla Respiratory (IFV-RSV) Panel Clinical Testing and Sample Collection Protocol in Support of 510(k) Premarket Submission
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Product performance as measured by positive and negative agreement to a predicate
研究概览
简要总结
This clinical study will collect fresh samples and perform laboratory testing on fresh and archived samples as described in the protocol.
详细描述
The Idylla console, instrument, and Respiratory (IFV-RSV) Panel cartridge constitute the Idylla respiratory diagnostic system. The IFV-RSV Panel is an in vitro PCR-based molecular diagnostic assay for the simultaneous qualitative detection of nucleic acids for Influenza A (including H1, 2009 H1N1, H275Y mutation of 2009 H1N1, H3), Influenza B, and Respiratory Syncytial Virus (RSV) (A and B) on nasal swab (NS) direct to cartridge or nasopharyngeal swabs (NP) in viral transport media (VTM) in adults, adolescents, and children.
This clinical study will collect data in support of regulatory submission and the indications for use of the IFV-RSV panel and the Idylla diagnostic system. This protocol will demonstrate that the results of this assay, in conjunction with clinical information, may be used as an aid in the diagnosis of infection with Influenza A, Influenza B, and RSV in persons having both a high and low risk for respiratory viral infection.
During this study, participating sites will collect fresh samples, conduct a Reproducibility Study and test the fresh and previously collected frozen samples from individuals presenting with signs/symptoms of influenza like illness (ILI) and respiratory virus in accordance to the sample collection described in this protocol.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Subject, or legally authorized representative, has provided IRB/EC approved written Informed Consent, privacy (e.g. HIPAA) authorization when required and Assent where applicable prior to any study-related procedure(s) being performed
- •Patient presenting with ILI and/or Signs/Symptoms of RSV Infection as defined in this protocol
- •Onset of ILI and/or Signs/Symptoms of RSV Infection was ≤ 5 days prior to subject screening (Refer to the definitions for detailed descriptions of ILI and Signs/Symptoms of RSV infection)
- •Clinician's determination that illness is due to a viral infection
- •Subject agrees to allow study specimens to be used for future studies
排除标准
- •Onset of Influenza Like Illness (ILI) and/or Signs/Symptoms of RSV Infection was > 5 days prior to subject screening (Refer the definitions for detailed descriptions of ILI and Signs/Symptoms of RSV infection)
- •Subject received live intranasal attenuated influenza virus in last 3 weeks (e.g. FluMist, Fluenz)
- •Subject received treatment with influenza directed antiviral (e.g. Zanamivir, oseltamivir (Tamiflu), amantadine, rimantadine) in the last 5 days
- •The subject was previously enrolled in this study
- •Clinician's determination that illness is NOT due to a viral infection (e.g. allergies)
- •Subject had a nasal wash within last 8 hours. This exclusion includes any extraction of nasal secretions by nasal suctioning with fluid
- •Subject does not agree to allow study specimens to be used for future research studies
结局指标
主要结局
Product performance as measured by positive and negative agreement to a predicate
时间窗: Specimen collected during the IFV-RSV season 2015/2016 will be tested within 1 day of enrollment. The Product Performance will be assessed at study completion, an average of 6 months.
Product Performance will be assessed based on samples collected in 2015/2016 season (average of 6 months) and archived samples.
次要结局
未报告次要终点